Our patent office recently issued a decision in Cipla’s (Opponent) favor in a pre-grant opposition proceeding against Novartis (Applicant). The opposition proceedings were brought under sections (25(1)(e), (25(1)(f), and (25(1)(h) of the Patents Act. The Controller (Dr. Subramaniyan, Chennai office) decided the issue of novelty in favor of the Applicant, and decided the issues of inventive step and non inventiveness (section 3) in favor of the opponent. A brief introduction to the grounds is followed by our comments.
Inventive step: The Controller held that “There is no detailed method for the preparation of the dispersible tablet with four phases…..It appears that the applicant is not clear on the phases involved in the method of preparation of the dispersible tablet. Moreover there are no specific teachings pertaining to process parameters for preparing phase I and adding the phase II onto the phase I provided in the description. Further all the steps involved in the preparation of dispersible tablet of the present invention are conventional and routine in the pharmaceutical formulation industry, but there are no specific improvements with specific details provided in the description.” Paragraph 17, at page 8.
The Controller held that the dosage of the invention fell within the range as provided in prior art and altering the dose and dosage regimen within the range of the art could not be considered to be inventive. Additionally, there was no inventive step in independent claim 1 because the dispersible tablet as one of the choice of medicament and the dosage range was disclosed in the prior art.
The Controller found that the Applicant had failed to disclose: (1) the API and all excipients specifically with proportion in any composition or new drug delivery system for a known drug; and (2) support pertaining to unforeseen effect of the composition or new drug delivery system for the known drug with the closest prior art shall be provided in the specification.
Hence claims 1, 2, 13 and their dependent claims did not involve an inventive step and hence opposition was allowed under section 25(1)(e) of the Act.
Not an invention under section 3: While considering the arguments made by the opponent and the applicant, the Controller laid down three specific requirements that the applicant had to follow (Paragraph 28 at page 13):
(1) All the components of the invention shall be incorporated in the principal claim to make invention novel and inventive.
(2) All the necessary ingredients including the API and excipients shall be incorporated with proportion of each ingredient in the principal claim.
(3) Support relating to unexpected synergistic effect shall be incorporated in the specification.
The Controller in paragraph 29, mentioned that “[E]ven subject matters of claim 1, 2, and 10 have been (sic) combined to form a composition claim, it is still considered to be an admixture, because each of the ingredient present in the composition functioning as per the intended purpose, the total effect is an additive effect.”
The claims may read upon previous ranges, but that doesn’t make it obvious to do the more specific ranges… if it produces a better result, and no one has done it before, there’s a reason.
Welcome to the forum Michael!
In the US, MPEP 2144.05 provides for obviousness of ranges:
“In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists.”
Your statement about better results seems to be more akin to the species and genus issue. Again the same section provides:
“However, if the reference’s disclosed range is so broad as to encompass a very large number of possible distinct compositions, this might present a situation analogous to the obviousness of a species when the prior art broadly discloses a genus.”
The Indian law is similar to the US on this account and hence the rejection (for obviousness of range) is proper under both US and Indian laws.
What would you say about the rejection of the claimed compound being a mere admixture?
In such cases, it is a burden placed on the applicant to demonstrate that the narrow range provides an unexpected and surprising benefit over the broad disclosure of the prior art. It needs to be shown to have been a purposive selection.
I am not sure if the ranges are covered under section 3(d). Rajiv can you please clarify that? Section 3(d) “The mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant is not an invention.”
I think that the issue of ranges does not fall under this section. The issue of ranges should fall under 2(1)(j) and 2(1)(ja).
r!nKz: You are correct. Ranges do not fall under 3(d). They fall under 2(l)(j) and 2(l)(ja). See
N/PCT/2002/00020/DEL where it was held that the selection of particular range of ingredients from the ranges already known prior art in this case cannot amount to establish the inventive step and the variations in the amounts of the known ingredients
appear merely workshop improvements achieved by a person skilled in the art without performing any substantial experiments and can not be said a technical advancement of an existing knowledge which is required by the definition of the “inventive step” as mentioned in section 2(l)(ja) of the Patents Act, 1970.